BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITY DOCKING STATION

    MDR report key: 998175 · Received February 8, 2008

    Report

    Report Number
    1220063-2008-00003
    Event Type
    Malfunction
    Date Received
    February 8, 2008
    Date of Event
    December 20, 2007
    Report Date
    February 7, 2008
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC.
    Product Code
    MHX
    Removal / Correction Number
    2517967-11/16/06-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OUR EVALUATION CONFIRMED THAT THE TOP COVER OF THE DEVICES ACTUALLY SEPARATED FROM THE BASE AS REPORTED. WE ALSO FOUND THAT ONE OF THE UNITS WAS MODIFIED (TOP COVER GLUED TO BASE) BY THE CUSTOMER. THIS IS A KNOWN SUPPLIER ISSUE AND WE HAVE IMPLEMENTED SUPPLIER CORRECTIVE ACTION AND INITIATED A FIELD CORRECTION. THE DEVICES IDENTIFIED IN THIS INCIDENT FALL IN THE RANGE OF THE POTENTIALLY DEFECTIVE DEVICES OF THE FIELD CORRECTION.

    Description of Event or Problem · 1

    DRAEGER MEDICAL SYSTEMS, INC. HAS RECEIVED INFORMATION FROM A CUSTOMER WHO HAS REPORTED THAT TWO OF OUR INFINITY DOCKING STATIONS (IDS) UNITS WERE FOUND TO HAVE SEPARATED (TOP COVER FROM THE BASE COMPONENT). NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFINITY DOCKING STATION PATIENT MONITOR DOCKING STATION MHX DRAEGER MEDICAL SYSTEMS, INC. 5206110 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI